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Recruiting NCT05819229

Oral Antibiotics Alone in Children Aged 4 Weeks to 2 Months With a Urinary Tract Infection

Trial Parameters

Condition Urinary Tract Infections in Children
Sponsor Rigshospitalet, Denmark
Study Type OBSERVATIONAL
Phase N/A
Enrollment 125
Sex ALL
Min Age 4 Weeks
Max Age 2 Months
Start Date 2023-02-27
Completion 2025-04-01
Interventions
Oral antibiotic therapy

Brief Summary

The goal of this prospective study is to investigate whether oral antibiotic therapy alone is feasible and safe in clinically stable children aged 4 weeks to 2 months without any past high-risk medical history with a suspected or confirmed urinary tract infection.

Eligibility Criteria

INCLUSION CRITERIA: 1. Clinical suspicion of urinary tract infection irrespective of the presence of fever. 2. Clinically stable (i.e., not respiratory or circulatory affected, septic, or meningeal). 3. 4 weeks to 2 months of age (corrected age, if premature). All children who do not receive any empirical antibiotic therapy but have a positive urine culture can be included if the clinical suspicion of urinary tract infection persists. A positive urine culture is defined as: * Suprapubic bladder aspiration: any growth of bacteria. * Sterile intermittent catheterization: monoculture with ≥10\^3 colony forming units per milliliter (cfu/ml). * Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^4 cfu/ml. * Midstream urine x 2: monoculture with the same bacteria in both tests with ≥10\^5 cfu/ml in one test and 10\^3 cfu/ml in another test. EXCLUSION CRITERIA: 1. Non-Danish civil registration number. 2. High-risk medical history. 1. Previous urinary tract infectio

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